Rolapitant side effects: what 538 FDA adverse event reports show

Rolapitant · Varubi · 6 reaction terms · 102 drug–reaction co-reports · data 2026-09-14

Drug class

Substance p/neurokinin 1 (nk1) receptor antagonist

FDA label, Indications wording

Brand names

Varubi

openFDA label

Who reports

538 reports · 78% serious · 163 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VARUBI ® is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

FDA label, Indications and Usage

What it is

VARUBI contains rolapitant, a substance P/neurokinin 1 (NK1) receptor antagonist. Rolapitant hydrochloride is chemically described as (5S,8S)-8- { [(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]methyl]}-8-phenyl-1,7-diazaspiro[4.5]decan-2-one hydrochloride.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 4 strongest signals

Lab value / disease marker 1Not in label — unassessed 3

What the badges mean

Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Infusion related reaction (reaction during infusion)	40	23.6 17.5–31.8ROR 25.4 · χ² 846 / p 3e-186	23.4 EB05 17.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 20.5 · 100% clinician	no trial data cached
Plasma cell myeloma	16	16.0 9.8–25.9ROR 16.4 · χ² 210 / p 7e-48	15.2 EB05 9.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	no trial data cached
Blood count abnormal	6	15.2 6.9–33.7ROR 15.4 · χ² 66 / p 2e-16	11.7 EB05 4.4 · IC025 +1.4 3/3 methods agree	Lab value / disease marker	serious PRR 15.8	no trial data cached
Flushing	32	12.2 8.7–17.1ROR 12.9 · χ² 320 / p 8e-72	11.8 EB05 8.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 21.1 · 100% clinician	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Infusion related reaction (reaction during infusion)	40	23.6 17.5–31.8ROR 25.4 · χ² 846 / p 3e-186	23.4 EB05 17.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 20.5 · 100% clinician	no trial data cached
Flushing	32	12.2 8.7–17.1ROR 12.9 · χ² 320 / p 8e-72	11.8 EB05 8.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 21.1 · 100% clinician	no trial data cached
Plasma cell myeloma	16	16.0 9.8–25.9ROR 16.4 · χ² 210 / p 7e-48	15.2 EB05 9.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	no trial data cached
Blood count abnormal	6	15.2 6.9–33.7ROR 15.4 · χ² 66 / p 2e-16	11.7 EB05 4.4 · IC025 +1.4 3/3 methods agree	Lab value / disease marker	serious PRR 15.8	no trial data cached
Product adhesion issue	4	4.4 1.7–11.7ROR 4.4 · χ² 7 / p 0.003	3.2 EB05 1.4 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Hospice care	4	15.8 6.0–42.0ROR 15.9 · χ² 42 / p 5e-11	10.0 EB05 3.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Infusion related reaction — n=40, PRR 23.6
Flushing — n=32, PRR 12.2

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Rolapitant?

In FDA FAERS, the most frequently co-reported reaction terms for Rolapitant are infusion related reaction, flushing, plasma cell myeloma, blood count abnormal, hospice care. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Rolapitant have an FDA boxed warning?

No. The FDA label retrieved for Rolapitant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Rolapitant causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 8670c3cf-82d9-466d-be49-de33d8c8742b, effective 20260908; matched on openfda.generic_name.exact:"ROLAPITANT")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 6 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.